UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043107 |
|---|---|
| Receipt number | R000048410 |
| Scientific Title | Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine) |
| Date of disclosure of the study information | 2021/01/23 |
| Last modified on | 2023/01/26 09:00:11 |
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Basic information
Public title
Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)
Acronym
Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)
Scientific Title
Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)
Scientific Title:Acronym
Association between hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine)
Region
| Japan |
Condition
Condition
Man and women
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examined the association of hie disorder physical and hie(cold disorder) scale, oriental medicine state (Five Viscera and Constitution in Chinese Medicine).
Basic objectives2
Others
Basic objectives -Others
Internet survey, cross-sectional research, the association of hie disorder physical and oriental medicine state (Five Viscera and Constitution in Chinese Medicine).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The contents of the survey were age, sex, hie disorder status, hie disorder physical of numerical rating scale(NRS), hie scale, Five Viscera Score and Constitution in Chinese Medicine Questionnaire (CCMQ).
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the subjects were Japanese women and man living in Japan.
Key exclusion criteria
the study were age, those who did not fill in the survey items.
Target sample size
302
Research contact person
Name of lead principal investigator
| 1st name | ryouta |
| Middle name | |
| Last name | tsuji |
Organization
Morinomiya University of Medical Sciences
Division name
Department of acupuncture and moxibustion,Faculty of Health Sciences
Zip code
559-8611
Address
1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611
TEL
+81-6-6616-6911
tsuji@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | hiroshi |
| Middle name | |
| Last name | kuge |
Organization
Osaka Medical College Hospital
Division name
Department of Anesthesiology pain clinic
Zip code
569-8686
Address
2-7, daigakumachi Takatsuki city, Osaka prefecture, 569-8686
TEL
+81-90-1487-1151
Homepage URL
sherry@kha.biglobe.ne.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Morinomiya University of Medical Sciences
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Morinomiya University of Medical Sciences
Address
1-26-16, nankoukita suminoeku oosaka city, Osaka prefecture, 559-8611
Tel
+81-6-6616-6911
tsuji@morinomiya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2020 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Internet survey, cross-sectional research
Management information
Registered date
| 2021 | Year | 01 | Month | 23 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048410
